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The Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings

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The Week Ahead In Biotech Feb. 28-March 6: KemPharm, Gilead FDA Decisions and More Earnings

Biotech stocks extended their losses in the week ended Feb. 26 amid continued weakness in the broader market. Earnings came in thick and fast, with a skew of small and midcap companies releasing their quarterly results.

Sarepta Therapeutics Inc (NASDAQ: SRPT) won a regulatory nod for its Amondys 45 drug for treating certain types of Duchenne muscular dystrophy. This is the company's third product in a portfolio of related drugs to have received approval.

Merck & Co., Inc. (NYSE: MRK) announced a deal to buy Pandion Therapeutics Inc (NASDAQ: PAND), a company that focuses on therapies for autoimmune disorders, for $1.85 billion.

Moderna Inc (NASDAQ: MRNA) and the duo of Pfizer Inc. (NYSE: PFE)-BioNTech SE – ADR (NASDAQ: BNTX) revealed their strategies for emerging coronavirus variants. The companies said they would test additional booster doses as well as variant-specific vaccines.

The week also witnessed multiple clinical readouts, while it was a relatively quiet week on the IPO front.

Here are the key events for the unfolding week:

Conferences

ESMO Targeted Anticancer Therapies Virtual Conference 2021: Feb. 28- March 2
Cowen 41st Annual Virtual Healthcare Conference: March 1-4
38th Annual Miami Breast Cancer Conference: March 4-7

PDUFA Dates

The Food and Drug Administration is scheduled to issue its verdict on KemPharm Inc's (NASDAQ: KMPH) new drug application for KP415, which is being evaluated for the treatment of attention deficit hyperactivity disorder. The decision is due Tuesday, March 2. KemPharm is collaborating with Aquestive Therapeutics Inc (NASDAQ: AQST) for an oral film dosage of KP415.

Gilead Sciences, Inc. (NASDAQ: GILD) has a PDUFA date of Friday, March 5, by which the FDA will decide on Yescarta, or axicabtagene ciloleucel. It is being evaluated for the treatment of certain types of lymphoma. Yescarta is a CAR T-cell therapy that came into Gilead's stable through its acquisition of Kite.

Clinical Readouts

At the ESMO meeting, Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) will present safety, tolerability and preliminary efficacy of poziotinib, a lung cancer drug. The presentation is scheduled for Tuesday, March 2, at 11:25 a.m.

Related Link: Novavax Achieves Target Enrollment In Pivotal Phase 3 Coronavirus Vaccine Study In US, Mexico

Earnings

Monday

Reata Pharmaceuticals Inc (NASDAQ: RETA) (before the market open)
Axsome Therapeutics Inc (NASDAQ: AXSM) (before the market open)
Amicus Therapeutics, Inc. (NASDAQ: FOLD) (before the market open)
Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) (before the market open)
Athenex Inc (NASDAQ: ATNX) (before the market open)
Agile Therapeutics Inc (NASDAQ: AGRX) (after the close)
Atara Biotherapeutics Inc (NASDAQ: ATRA) (after the close)
Arcturus Therapeutics Holdings Inc (NASDAQ: ARCT) (after the close)
Adverum Biotechnologies Inc (NASDAQ: ADVM) (after the close)
Omeros Corporation (NASDAQ: OMER) (after the close)
ChemoCentryx Inc (NASDAQ: CCXI) (after the close)
FibroGen Inc (NASDAQ: FGEN) (after the close)
Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the close)
Precigen Inc (NASDAQ: PGEN) (after the close)
Turning Point Therapeutics Inc (NASDAQ: TPTX) (after the close)
OraSure Technologies, Inc. (NASDAQ: OSUR) (after the close)
Regenxbio Inc (NASDAQ: RGNX) (after the close)
Xenon Pharmaceuticals Inc (NASDAQ: XENE) (after the close)
Sarepta Therapeutics Inc (NASDAQ: SRPT) (after the close)
Silk Road Medical Inc (NASDAQ: SILK) (after the close)
Novavax, Inc. (NASDAQ: NVAX) (after the close)

Tuesday

Antares Pharma Inc (NASDAQ: ATRS) (before the market open)
Eagle Pharmaceuticals Inc (NASDAQ: EGRX) (before the market open)
GlycoMimetics Inc (NASDAQ: GLYC) (before the market open)
Seres Therapeutics Inc (NASDAQ: MCRB) (before the market open)
TherapeuticsMD Inc (NASDAQ: TXMD) (before the market open)
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the close)
Neuronetics Inc (NASDAQ: STIM) (after the close)

Wednesday

Strongbridge Biopharma plc (NASDAQ: SBBP) (before the market open)
OptiNose Inc (NASDAQ: OPTN) (before the market open)
Passage Bio Inc (NASDAQ: PASG) (before the market open)

Thursday

Arbutus Biopharma Corp (NASDAQ: ABUS) (before the market open)
Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) (before the market open)
X4 Pharmaceuticals Inc (NASDAQ: XFOR) (before the market open)
Syros Pharmaceuticals Inc (NASDAQ: SYRS) (before the market open)
Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the close)
Acorda Therapeutics Inc (NASDAQ: ACOR) (after the close)
Anika Therapeutics Inc (NASDAQ: ANIK) (after the close)
INmune Bio Inc (NASDAQ: INMB) (after the close)
Synthetic Biologics Inc (NYSE: SYN) (after the close)
T2 Biosystems Inc (NASDAQ: TTOO) (after the close)
Evofem Biosciences Inc (NASDAQ: EVFM) (after the close)
DermTech Inc (NASDAQ: DMTK) (after the close)
Chiasma Inc (NASDAQ: CHMA) (after the close)
Fulgent Genetics Inc (NASDAQ: FLGT) (after the close)
Clearpoint Neuro Inc (NASDAQ: CLPT) (after the close)

IPO Quiet Period Expiries

Sana Biotechnology Inc (NASDAQ: SANA)
Sensei Biotherapeutics Inc (NASDAQ: SNSE)
Landos Biopharma Inc (NASDAQ: LABP)
Angion Biomedica Corp (NASDAQ: ANGN)
Bolt Biotherapeutics Inc (NASDAQ: BOLT)
Immunocore Holdings PLC – ADR (NASDAQ: IMCR)
Lucira Health Inc (NASDAQ: LHDX)
Evaxion Biotech A/S – ADR (NASDAQ: EVAX)
Terns Pharmaceuticals Inc (NASDAQ: TERN)
Pharvaris BV (NASDAQ: PHVS)
Vor Biopharma Inc (NASDAQ: VOR)
Adagene Inc (NASDAQ: ADAG)

Other Events

Avenue Therapeutics Inc (NASDAQ: ATXI), a Avenue Fortress Biotech (NASDAQ: FBIO) portfolio company, is due to resubmit its drug application for intravenous tramadol in February. The company received a complete response letter for the original application in mid-October.

Related Link: Why AstraZeneca Is Voluntarily Withdrawing Imfinzi In US For Advanced Bladder Cancer Indication

 

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